- Gilead has sole rights to COVID-19 blockbuster Veklury, GAO concludes (fiercepharma.com)
Throughout the frantic response to the pandemic last year, drugmakers worldwide tested hundreds of potential treatments. Gilead’s antiviral remdesivir quickly rose to the top of treatment guidelines, and with the pandemic spiraling out of control, advocacy groups called on the U.S. government to step in and enforce patents against the company...But it turns out the government has no intellectual property covering remdesivir, the Government Accountability Office concluded in a new report...READ MORE
- Tracking the success of Johns Hopkins’ high-profile COVID-19 website (healthcareitnews.com)Johns Hopkins Coronavirus Resource Center (coronavirus.jhu.edu)
Here's a look at how it was created, what it offers – and how it grew to reach more than 38 million visits in seven months...Amid the COVID-19 pandemic, Johns Hopkins Medicine needed to provide accurate content very quickly in an information environment that was changing by the hour...In a pre-pandemic world, the organization's content team would look to search engine optimization strategies to see what questions people are asking and determine what information would be most useful. However, that data was just not yet available for COVID-19 when the pandemic hit...READ MORE
- AstraZeneca’s COVID-19 vaccine defies data controversy with 76% effectiveness in phase 3 (fiercepharma.com)
AstraZeneca created a COVID-19 vaccine data controversy this week by reportedly selecting the most favorable data to tout on its program, a move independent data monitors publicly flagged in a middle-of-the-night missive. Now, with a speedy data update and analysis, AstraZeneca says it can “confirm” the vaccine’s phase 3 success...In a newly released primary analysis, AstraZeneca says its vaccine was 76% effective against symptomatic COVID-19 and 85% effective against symptomatic disease in people 65 and over. The shot was also 100% effective against severe disease and hospitalization in the phase 3 trial...READ MORE
- Overworked, understaffed: Pharmacists say industry is in crisis, putting patient safety at risk (msn.com)
From the moment Marilyn Jerominski walks into her pharmacy every morning, her time is in demand. As pharmacy manager of a busy 24-hour Walgreens in Palm Desert, California, she is responsible for the safety and accuracy of the thousands of prescriptions the store dispenses every week..."There's so much stress," Jerominski said. "You're not only running to the drive-thru but to the front, to the vaccination station to give a vaccination, then to the phone. ... It's almost impossible for any human to keep that momentum day in and out."...Jerominski is one of an estimated 155,000 pharmacists working at chain drugstores who, over the past decade, have found themselves pushed to do more with less. They're working faster, filling more orders and juggling a wider range of tasks with fewer staff members at a pace that many say is unsustainable and jeopardizes patient safety...READ MORE
- FDA downplayed serious red flags at Merck vaccine plant slated for J&J COVID shot, whistleblower says (fiercepharma.com)
An FDA inspector-turned-whistleblower claims the agency soft-pedaled violations at a range of pharma manufacturing plants, including a Merck & Co. vaccine facility in Durham, North Carolina, where staff allegedly destroyed evidence of unsanitary practices. Those allegations have now been passed along to the White House… The whistleblower alleged that employees at Merck's plant were moving between cleanrooms and uncontrolled areas without properly ungowning, and that a biohazard bin contained employee uniforms soiled with blood, urine and feces. Employees were soiling their uniforms rather than taking restroom breaks, the whistleblower claimed, citing a confidential informant, because staffers would have otherwise needed to remove sterile gowning and leave manufacturing areas…READ MORE
- WHO warns about fake COVID-19 vaccines on the dark web (healthcareitnews.com)
Forged vaccination certificates and fake negative tests are also reportedly available for purchase on the black market...The World Health Organization...issued a warning about counterfeit and stolen COVID-19 vaccines being sold on the dark web...Fake vaccination certificates are also being sold, as well as fake negative tests, aimed at those traveling abroad...The WHO is "aware of vaccines being diverted and reintroduced into the supply chain, with no guarantee that [the] cold chain has been maintained...READ MORE
- U.S. health officials raise concerns over AstraZeneca vaccine data (pharmacist.com)AstraZeneca accused of cherry-picking vaccine study data (apnews.com)Missteps could mar long-term credibility of AstraZeneca shot (apnews.com)
In an unusual move... officials with the National Institute of Allergy and Infectious Diseases urged AstraZeneca to ensure it is providing the most recent efficacy data on its coronavirus vaccine. The statement came 1 day after the manufacturer released interim data from its U.S. trials...NIAID...said an independent monitoring board informed it that AstraZeneca's disclosures of the study results may have been based on outdated evidence. The agency's response to the company...READ MORE
- Up to 15M Johnson & Johnson coronavirus vaccine doses ruined due to human error: NYT (fiercepharma.com)
Workers at an Emergent BioSolutions plant in Baltimore mixed up vaccine ingredients weeks ago and ruined a large batch of the vaccine containing up to 15 million doses...The FDA is investigating the mistake, but the episode has led to a temporary halt of future J&J shot deliveries from the site...In a statement, J&J said it's working with federal authorities to deliver 24 million doses of the vaccine in April...The mistake happened early in the production process, so none of the doses made it out to distribution...READ MORE
- New CDC study: mRNA vaccines 90% effective (msn.com)Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers — Eight U.S. Locations, December 2020–March 2021 (cdc.gov)
In their clinical trials, the Pfizer and Moderna vaccines did okay, well enough for the FDA to grant emergency use authorization. But in a real-world study, where participants were all on the front lines fighting Covid, the vaccines proved 90% effective against the virus – not just the symptomatic disease. In the clinical studies, Pfizer and Moderna were testing against disease...According to the CDC-sponsored study released today, it didn’t matter which vaccine the participants received. What mattered was that both vaccines were designed using messenger RNA to repel the coronavirus. The results showed that the vaccines were even effective against asymptomatic virus...READ MORE
- U.S. to share 4 million doses of AstraZeneca COVID-19 vaccine with Mexico, Canada (reuters.com)
The United States plans to send roughly 4 million doses of AstraZeneca's COVID-19 vaccine that it is not using to Mexico and Canada in loan deals with the two countries, yielding to requests to share vaccines with allies...Mexico will receive 2.5 million doses of the vaccine and Canada is to receive 1.5 million doses...The Biden administration has come under pressure from countries around the world to share vaccines, particularly its stock of AstraZeneca’s vaccine, which is authorized for use elsewhere but not yet in the United States...READ MORE